Access Device

ABSTRACT

Various devices and methods are provided with respect to inserting multiple surgical instruments through a single surgical access device. A medical device including a flexible tissue retractor a releasable insert having multiple instrument openings, and a member such as a sleeve is disclosed. The insert can be in the form of an insert assembly including multiple components. The sleeve can support the insert with respect to the retractor such that the insert and sleeve can be removed together with the retractor remaining in the incision. A method of using the insert is also described.

CROSS REFERENCE

This patent application incorporates by reference and claims priority toas a continuation in part of Devices and Methods for Providing AccessInto a Body Cavity, U.S. Ser. No. 12/479,418, filed Jun. 5, 2009; andthis patent application also incorporates by reference and claimspriority to Provisional Patent Application Ser. No. 61/165,080 filedMar. 31, 2009.

The present application cross references and incorporates by referencethe following commonly assigned U.S. patent applications: U.S. Ser. No.11/398,985 filed Apr. 5, 2006 and published as US20060247673; U.S. Ser.No. No. 11/399,181 filed Apr. 5, 2006; U.S. Ser. No. 11/399,145 filedApr. 5, 2006; U.S. Ser. No. 11/399,149 filed Apr. 5, 2006; U.S. Ser. No.11/399,044 filed Apr. 5, 2006; U.S. Ser. No. 11/399,172 filed Apr. 5,2006; U.S. Ser. No. 11/399,045 filed Apr. 5, 2006; U.S. Ser. No.12/242,765 filed Sep. 30, 2008; U.S. Ser. No. 12/242,711 filed Sep. 30,2008; U.S. Ser. No. 12/242,721 filed Sep. 30, 2008; U.S. Ser. No.12/242,383 filed Sep. 30, 3008; U.S. Ser. No. 12/242,333 filed Sep. 30,2008; U.S. Ser. No. No. 12/242,353 filed Sep. 30, 2008; U.S. Ser. No.12/242,381 filed Sep. 30, 2008; U.S. Ser. No. 12/399,625 filed Mar. 6,2009; U.S. Ser. No. 12/399,633 filed Mar. 6, 2009; U.S. Ser. No.12/399,547 filed Mar. 6, 2009; U.S. Ser. No. 12/399,656 filed Mar. 6,2009; U.S. Ser. No. 12/399,482 filed Mar. 6, 2009; U.S. Ser. No.12/399,473; U.S. Ser. No. 12/110,724 filed Apr. 28, 2008; U.S. Ser. No.12/109,881 filed Apr. 25, 2008; U.S. Ser. No. 12/425 filed Apr. 29,2008; and U.S. Ser. No. 12/172,349 filed Jul. 14, 2008.

FIELD OF THE INVENTION

The present invention relates to access devices, such as for providingsurgical access into a body cavity.

BACKGROUND OF THE INVENTION

Abdominal laparoscopic surgery gained popularity in the late 1980s, whenbenefits of laparoscopic removal of the gallbladder over traditional(open) operation became evident. Reduced postoperative recovery time,markedly decreased post-operative pain and wound infection, and improvedcosmetic outcome are well established benefits of laparoscopic surgery,derived mainly from the ability of laparoscopic surgeons to perform anoperation utilizing smaller incisions of the body cavity wall.

Laparoscopic procedures generally involve insufflation of the abdominal,cavity with CO2 gas to a pressure of around 15 mm Hg. The abdominal wallis pierced and a 5-10 mm in diameter straight tubular cannula or trocarsleeve is then inserted into the abdominal cavity. A laparoscopictelescope connected to an operating room monitor is used to visualizethe operative field, and is placed through a the trocar sleeve.Laparoscopic instruments (graspers, dissectors, scissors, retractors,etc.) are placed through two or more additional trocar sleeves for themanipulations by the surgeon and surgical assistant(s).

Recently, so-called “mini-laparoscopy” has been introduced utilizing 2-3mm diameter straight trocar sleeves and laparoscopic instruments. Whensuccessful, mini-laparoscopy allows further reduction of abdominal walltrauma and improved cosmesis. Instruments used for mini-laparoscopicprocedures are, however, generally more expensive and fragile. Becauseof their performance limitations, due to their smaller diameter (weaksuction-irrigation system, poor durability, decreased video quality),mini-laparoscopic instruments can generally be used only on selectedpatients with favorable anatomy (thin cavity wall, few adhesions,minimal inflammation, etc). These patients represent a small percentageof patients requiring laparoscopic procedures. In addition, smaller 2-3mm incisions may still cause undesirable cosmetic outcomes and woundcomplications (bleeding, infection, pain, keloid formation, etc.).

Since the benefits of smaller and fewer body cavity incisions areproven, it would be desirable to perform an operation utilizing only asingle incision in the navel. An umbilicus is well-hidden and thethinnest and least vascularized area of the abdominal wall. Theumbilicus is generally a preferred choice of abdominal cavity entry inlaparoscopic procedures. An umbilical incision can be easily enlarged(in order to eviscerate a larger specimen) without significantlycompromising cosmesis and without increasing the chances of woundcomplications. The placement of two or more standard (straight) cannulasand laparoscopic instruments in the umbilicus, next to each other,creates a so-called “chopstick” effect, which describes interferencebetween the surgeon's hands, between the surgeon's hands and theinstruments, and between the instruments. This interference greatlyreduces the surgeon's ability to perform a described procedure.

Thus, there is a need for instruments and trocar systems which allowlaparoscopic procedures to be performed entirely through the umbilicusor a surgical port located elsewhere while at the same time reducing oreliminating the “chopstick effect.”

SUMMARY OF THE INVENTION

The present invention generally provides devices for allowing surgicalaccess to an interior of a patient's body.

In one embodiment, the medical device comprises a tissue refractor andan insert releasably supported within a passageway associated with thetissue retractor. The insert may have an outer surface sized and shapedto deform a flexible member of the tissue retractor to provide at leasta portion of the passageway with a predetermined size and shape.

The insert can be in the form of an insert assembly having a generallycylindrical outer surface sized to radially stretch a portion of thetissue retractor to have a generally circular or other suitablecross-section of predetermined diameter or width upon insertion of theinsert within the passageway.

The tissue retractor may be a flexible tissue retractor which includes aflexible member, such as a flexible membrane, having a first end and asecond end, and the insert may be releasably supported or otherwisereleasably insertable within the passageway of the flexible tissueretractor.

In one embodiment, the insert comprises an assembly having an innerportion and an outer portion. The outer portion can have a generallycylindrical outer surface adapted to engage the inner surface of thepassageway of the tissue retractor, and the inner portion may include aplurality of instrument openings aligned with instrument passagewaysrotatable with respect to the outer portion of the insert and theflexible tissue retractor.

The insert may comprise an assembly which includes an outer body portionsized and shaped to engage and deform a portion of the inner surface ofa flexible tissue retractor, a housing disposed at least partiallywithin the outer sleeve, at least one instrument opening in an uppersurface of the housing, and at least one seal operatively associatedwith each instrument opening. The insert assembly may also include aninstrument channel member in the form of a unitary, flexible structuredefining a plurality of tubular instrument channels. Each tubularinstrument channel may be independently deformable with respect to thehousing and the other tubular instrument channels. The instrumentchannels and instrument openings may be rotatably supported with respectto the outer sleeve and the tissue retractor, such as by a bearingmember

In one embodiment the flexible tissue refractor comprises first andsecond deformable rings, and the insert is sized and shaped to passthrough at least one of the rings without deforming the ring. The insertmay be sized and shaped to deform a portion of a flexible memberextending intermediate the first and second rings

In one embodiment, an assembly comprising a flexible tissue retractor,an insert, and a sleeve is provided. The sleeve may be positioned in theflexible tissue retractor, and the insert may be pressed into thesleeve. The sleeve and insert may be removed together from the retractorwithout removing the retractor from the incision. The sleeve may beprovided to assist in inserting and removing the insert, and the sleevemay be formed of a material having a relatively low coefficient offriction, and a relatively high puncture resistance and/or hightoughness

In one embodiment, a method for accessing a body cavity through inincision is provided. The method includes the steps of positioning atissue retractor in the incision; and releasably positioning an inserthaving multiple instrument openings into the tissue retractor. The stepof positioning the insert may be by pressing the insert into the tissueretractor, and may include deforming and/or stretching at least aportion of the tissue retractor. The method may include forming anincision, positioning a tissue retractor in the incision, positioning asleeve to extend at least partially within the tissue retractor, andpositioning an insert having one or more instrument openings into thesleeve

In one embodiment, a medical device is provided including a tissueretractor, at least one insert having at least one instrument opening,where the insert is positionable, such as by pressing, at differentinsertion depths within a passageway of the tissue retractor.

In one embodiment, a method for accessing a body cavity includes thesteps of positioning a flexible tissue retractor in the incision,wherein the tissue retractor provides a passageway extending through theincision; releasably positioning a first insert having at least oneinstrument opening in the passageway provided by the flexible tissueretractor; removing the first insert from the passageway provided by thetissue retractor; and positioning a second insert having at least oneinstrument opening in the passageway. The second insert can have adifferent number of instrument openings and/or a different size and/or adifferent shape than that of the first insert. The method can alsoinclude repositioning an insert to a second depth in the passageway ofthe retractor.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a perspective, proximal view showing an access devicecomprising an insert having at least one instrument opening releasablysupported within a flexible tissue retractor, with the proximal end ofthe insert shown inserted to be positioned below an upper, proximal endof the flexible tissue retractor;

FIG. 2 is a perspective, distal view of the insert and flexible tissueretractor shown in FIG. 1, with a distal, bottom end of the insert shownvisible from a lower, distal opening of the flexible tissue retractor;

FIG. 3 is a cross-sectional view of a device of the type shown in FIG.1;

FIG. 4 is an exploded view of an insert of the type shown in FIG. 1;

FIG. 5 is a perspective, proximal view showing an alternative accessdevice comprising an assembly of an insert, a flexible tissue retractor,and a sleeve, the sleeve shown as including a generally annular portiondisposed over the proximal end of the flexible tissue retractor, and thesleeve shown as including a generally cylindrical portion extendingdistally from the annular portion, at least a portion of the generallycylindrical portion of the sleeve disposed between the insert and theflexible tissue retractor.

FIG. 6 is a cross-sectional view of the device of the type shown in FIG.5, and showing the generally cylindrical portion extending distallybeyond the distal end of the tissue retractor and the insert, the distalend of the cylindrical portion shown having a member in the form of agenerally circumferentially extending rib or ledge for preventing theinsert from being pressed into the body cavity and to assist inwithdrawing the insert from the tissue retractor.

FIG. 7 is an schematic exploded view of an insert similar to that shownin FIG. 4, but having three versus four instrument openings, includingone relatively larger instrument opening (such as to receive alaparascope or other relatively larger diameter device), and tworelatively smaller instrument openings (such as to receive relativelysmaller devices, such as 5 mm graspers, clip appliers, or the like).

FIG. 8 is a schematic depiction of how the insert of FIG. 7 can beinserted into a sleeve (shown in half section), and the insert andsleeve can, in turn, be inserted into a flexible tissue retractor (alsoshown in half section).

FIG. 9 illustrate the insert, sleeve, and tissue retractor positioned intissue, with the insert shown inserted into and supported by the sleeve,and the sleeve, in turn, supported in the tissue retractor, with thesleeve and retractor shown in half section, and FIG. 9 illustrating thesleeve having a length longer than the axial length of the retractor,such that the sleeve can be positioned at various depths within theretractor, and such that in FIG. 9 the distal portion of the insert isshown positioned below the abdominal wall, and the distal portion of theinsert abutting a retention feature in the form of an internal lip atthe distal end of the sleeve, the retention feature preventing theinsert from being pushed through the sleeve and into the abdominalcavity, and the lip facilitating removal of the insert with the sleevewhen the sleeve is withdrawn from the flexible retractor.

FIG. 10 is a perspective view illustrating how the sleeve and insert canbe removed by fingers of a single hand grasping the edges of the sleeveand lifting the sleeve proximally (upward in FIG. 10), with the insertretained by the sleeve and the insert being removed along with thesleeve when the sleeve is withdrawn from the retractor, and with theretractor left in place in the incision.

FIG. 11 is a perspective view showing how, once the sleeve and inserthave been removed from the flexible retractor, a specimen and/orspecimen bag can be removed from the body through the flexibleretractor.

FIG. 12 is a cross-sectional schematic illustration of an embodimentwhere an insert is disposed within a flexible retractor, where theflexible retractor has an internal retention future in the form of aninternal rib for retaining the insert at a desired depth within theretractor, and FIG. 12 illustrating how the insert's flexible supportwithin the retractor allows an instrument extending through the insertto pivot the insert itself, such as to provide an improved range ofmotion of the instrument over seals mounted above or below theretractor.

FIG. 13 provides a schematic cross-sectional illustration of an insert,sleeve, and retractor, where the insert includes zero closure seals inthe form of duckbill seals at the proximal end of the insert for sealinginstrument access channels when no instrument is inserted through thechannel, and instrument seals in the form of septum seals for sealingabout instruments inserted into the instrument channels.

DETAILED DESCRIPTION OF THE INVENTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

The present invention generally provides a medical device, such as asurgical access assembly, that allows one or more surgical instrumentsto be inserted through a single incision surgical access device, such asat various depths of insertion, thereby allowing for ease ofmanipulation of instruments within a patient's body while maintaininginsufflation.

FIG. 1 is a perspective view of the top, or proximal portion of theaccess assembly, and FIG. 2 is a perspective view of the bottom, ordistal portion of the access assembly. Referring to FIGS. 1 and 2, inone embodiment the medical device is in the form of an access assemblycomprising a flexible tissue retractor 1000 and an insert 2000 having atleast one instrument opening 2014 (four instrument openings 2014 shownin FIG. 1, and four instrument exits 2016 shown in FIG. 2). Theinstrument openings 2014 may extend through a top surface 2702 of aportion of the insert, and the openings 2014 may be closed or otherwiseobstructed by a membrane seal 2600, as described in more detail below.

The insert 2000 is shown releasably supported within a passageway 1104defined by a flexible member 1100 of the retractor 1000. The phrase“releasably supported” in this context means the insert can be insertedand removed from the tissue retractor multiple times, including during asurgical procedure, without damaging or otherwise impairing the functionof the retractor or the insert. In one illustrative example, the insert2000 is releasably inserted by pressing (such as with a thumb or finger)the insert into the passageway of the retractor.

The flexible member 1100 can include a first generally annular shaped,outer or top portion 1120 (oriented generally horizontally in FIG. 1), asecond generally annular shaped, inner portion 1160 (oriented generallyhorizontally and generally parallel to portion 1120 in FIG. 1), and agenerally cylindrically shaped portion 1140 extending axially in adistal direction from portion 1120 to portion 1160.

The outer portion 1120 can be associated with a first, proximal end 1101of the flexible member 1100, and the inner portion 1160 can beassociated with a second, distal end 1103 of the flexible member 110.The outer portion 1120 is disposed outside the patient's body when theflexible retractor is positioned during surgery, and the inner portion1160 is disposed within the patient, such as within a body cavity,during a surgical procedure. An inner surface of the generallycylindrical portion 1140 may provide most or substantially all of thepassageway 1104, while an outer surface of the generally cylindricalportion 1140 may contact the walls of an incision when the flexibleretractor 1000 is positioned during surgery, such as is shown in FIG. 3.

The flexible member 1100 may comprise a unitary, flexible membraneforming the portions 1120, 1140, and 1160, and having a first surface1102 and a second surface 1106. The passageway 1104 of tissue retractor1000 may be defined at least in part by a portion of the first surface1102 facing radially inwardly in generally cylindrical portion 1140. Theportion of the second surface 1106 associated with the generallycylindrical portion 1140 may face radially outwardly so as to contact orotherwise engage the tissue at the incision site.

The flexible tissue retractor 1000 may also comprise proximal and distalmembers for providing engagement of outer and inner portions of theretractor with outer and inner portions of the patient. For instance,the tissue retractor 1000 may include a resilient, outer (proximal)deformable ring 1200 and a resilient, inner (distal) deformable ring1400. Rings 1200 and 1400 are shown in phantom in FIGS. 1 and 2, and incross-section in FIG. 3. The flexible member 1100 is shown extendingintermediate the rings 1200 and 1400, such that member 1100 extends fromring 1200 to ring 1400.

FIG. 3 shows the access assembly of flexible retractor 1000 and insert2000 positioned in an incision such that the distal portion 1160 of theretractor 1000 and the ring 1400 are disposed in the abdominal cavity40, and the such that tissue 60 (including a portion of the abdominalwall) engages the surface 1106 of the flexible retractor.

The rings 1200 and 1400 can have any suitable closed or substantiallyclosed configuration, including without limitation circular, oval, andelliptical configurations. By “resilient deformable ring” it is meantthat the ring may be relatively easily deformed, such as by pressingopposite sides of the ring together with the fingers (and without anyadditional tools or aids), so that the ring may be inserted through anarrow incision in a body wall (e.g. the abdominal wall). For instance,the inner ring 1400 may be deformed, such as by pressing opposite sidesof the ring together with the fingers, and inserted through an incisionin the patient, such as an incision through the abdominal wall. Once thering is fully inserted, the inner ring 1400 is able to resilientlyreturn to its undeformed shape. The ring assists in securing theretractor 1000 within the incision by engaging the inside surface of theabdominal wall of the abdominal cavity.

The flexible member can comprise a flexible membrane of a resilientlydeformable material, such as natural rubber, silicone, or a suitabledeformable elastomer or elastomeric material. The deformable rings canbe attached to the flexible membrane, or enclosed within rolled ends ofthe membrane. One suitable flexible tissue retractor comprising aflexible member with inner and outer deformable rings is a tissueretractor available from Hakko as Hakko FF0707.

The flexible tissue retractor can be provided in one or more sizes, andin one example has a length, or height (measured in the direction ofaxis 70 in FIG. 3) of between about 1.5 mm and about 30 mm, a maximumdiameter corresponding to the diameter of the rings 1200/1400 of about40 mm to about 80 mm, and an inner passageway diameter of between about20 mm to about 40 mm. In the figures, the rings are shown havinggenerally the same diameter, but it will be understood that the diameterof the ring 1200 may selected to be greater than that of ring 1400, orthe diameter of ring 1200 may be less than that of ring 1400. In oneembodiment, a flexible tissue retractor having an inner passagewaydiameter smaller than that required to permit passage of a user's handand generally less than about 50 mm can be desirable, so as to provide aaccess for multiple instruments but without requiring a relatively largeincision.

The flexible tissue retractor 1000 may be formed to have a selfsupporting predefined shape, such as the shape shown in FIG. 1. By “selfsupporting” it is meant that when the retractor 1000 is placed on asubstantially horizontal surface (e.g. flat table top), the retractor isable to maintain its shape without collapsing, with the passageway 1104extending substantially vertically and with the portions 1120 and 1140separated a predetermined distance from each other by portion 1160.

In FIGS. 1-3, the insert 2000 is shown pressed into or otherwisepositioned within a passageway 1104 such that insert 2000 and theinstrument openings 2014 are disposed below the ring 1200 and theannular portion 1120 of the flexible tissue retractor. As shown in FIG.3, a member such as a retention feature in the form of an internal rib1108 may be formed with or otherwise provide on the internal surface ofthe retractor. The rib 1108 can be positioned to prevent the insert 2000from being pushed through the retractor 1000 and into the body cavity40.

In FIGS. 2 and 3, the distal end of the insert 2000 and the instrumentexits 2016 are shown extending generally at or below the distal ring1400 and the distal portion 1160 of the flexible retractor. Accordingly,the insert 2000 is positioned within the retractor 1000 to provide a lowprofile, such that the instruments inserted into the openings 2014 andout of the exits 2016 can be pivoted with respect to the insert 2000and/or each other at pivot points positioned distally of the upper,proximal ring 1200, such as at pivot points positioned within theincision. Such a low profile configuration allows seals associated withthe instrument passageways in the insert 2000 to reside below ring 1200,and in particular, within the incision or within the abdominal cavity.Without being limited by theory, it is believed that positioning sealsin the abdominal space may assist in preventing the seals from beingcollapsed or otherwise affected by tissue pressure, and may preventtissue from closing instrument passageways or otherwise blocking orreducing visibility through the instrument passageways.

Referring to FIGS. 3 and 4, the insert 2000 shown comprises an insertassembly. The insert assembly is shown comprising an outer body portion2100, a bearing member 2200, an inversion constraint member 2300, aspacer 2400, an elastomeric instrument channel member 2500, a membraneseal 2600, and an inner housing 2700, as described more fully below.

Outer body portion 2100 is shown in the form of a generally cylindricalshell having a generally cylindrical outer surface 2110, an innersurface 2112, a distal ledge 2120 extending radially inwardly fromsurface 2112, and an internal surface feature, such as acircumferentially extending protrusions 2114.

The outer body portion 2100 may be a generally rigid, hard shell formedof a suitable material, such as polyethylene or other suitable medicalgrade materials, so that when the insert 2000 is inserted into theflexible retractor 1000, the outer body portion 2100 does not deform toany significant degree, but instead acts to stretch or otherwise expandthe flexible retractor to maintain the passageway 1104 in a desiredshape and size, or to provide the passageway with a predetermined sizeand shape.

The outer body portion 2100 shown may inserted into the retractor todeform the portion of the retractor spaced from and intermediate therings 1200 and 1400. The outer body portion 2100 can be sized and shapedto pass through one or both rings 1200 and 1400 without deforming therings. For instance, outer body portion 2100 may have a generallycylindrical outer surface having an outer diameter smaller than theinner diameter of ring 1200, and the outer surface can be sized toradially and circumferentially stretch the portion of the retractorassociated with passageway 1104. Accordingly, the insert 2000 mayprovide the passageway 1104 extending through the incision with agenerally circular cross-section of predetermined diameter. Theadvantages of ease of insertion of a flexible retractor are retained,while preventing the passageway 1104 from being narrowed or constrictedby the incision. In addition, an insert having a generally cylindricalconfiguration provides a generally circular opening through theretractor, with a circle providing the maximum area per unit ofperimeter length. A generally circular cross-section of the insert alsoallows for ease in providing for rotation of a portion of the insert,such as with respect to the outer surface of the insert and/or theretractor.

In one embodiment, the outer diameter of the body portion 2100 may besized to be slightly larger than the inner diameter of passageway 1104when retractor is free standing, without the insert 2000 disposed in thepassageway 1104. After the retractor 1000 has been inserted into anincision, the insert 2000 may be inserted into retractor 1000. Theinsert 2000 may be sized to stretch the retractor, to at least slightlyenlarge the passageway 1104, and the insert 2000 can frictionally engagethe internal surface of passageway 1104. The insert 2000 can act to holdopen the passageway 1104 against the compressive forces of the incisionacting on the retractor 1000.

The outer body portion 2100 is shown having a generally cylindricalouter surface, but it will be understood that other outer surface shapesmay be employed, including generally smooth or faceted outer surfaces.Suitable surface include, but are not necessarily limited to oval,elliptical, ovoid, oblong, and combinations thereof. For instance, itmay be desirable to provide various inserts having different outersurface shapes and sizes to provide or assist in providing a passageway1104 having a certain size and shape, depending on for instance theprocedure being performed and/or the size of the incision. The size andshape of the outer surface of body portion 2100 may serve to deform theflexible member to provide at least a portion of the passageway with apredetermined size and shape. Additionally, the size and shape of theouter body portion may serve to provide frictional engagement of theouter body portion 2100 with the inner surface of the passageway 1104 inthe flexible retractor.

Still referring to FIGS. 3 and 4, the inner housing 2700 includes anouter proximally facing top surface 2702 through which instrumentopenings 2014 may extend. The inner housing 2700 shown also has agenerally cylindrical outer side surface 2710 extending distally fromthe top surface 2702. The instrument channel member 2500 is shownsupported within inner body portion 2700. The instrument channel member2500 defines a plurality of instrument channels 2550, each channel 2550generally aligned with and extending from a proximal opening 2014 to adistal exit 2016. The membrane seal 2600 is shown captured between theinner housing 2700 and a proximal end of the instrument channel member2500. The membrane seal 2600 provides a seal for preventing loss ofinsufflation through an instrument opening 2014 prior to insertion of aninstrument through the opening. The membrane seal 2600 may be in theform of a thin membrane formed of a flexible material which can bepunctured or otherwise pierced by a surgical instrument. In oneembodiment, the seal 2600 comprises a membrane formed of polyurethanehaving thickness of less than about 0.010 inch, and in particular themembrane can have a thickness of about 0.006 inch. Alternatively, zeroclosure seals such as a duck bill seal or other suitable seals forsealing in the absence of instrument may be employed in association withthe openings 2014.

The distal ledge 2120 of the outer body portion 2100 provides an axialthrust support surface on which bearing member 2200 may be rotatablysupported (see for instance FIG. 3). Bearing member 2200 may serve toprovide rotational support for an assembly comprising the inner bodyportion 2700 and instrument channel member 2500, such that the assemblyis able to rotate relative to the outer body portion 2100 about an axis70 extending generally longitudinally through the passageway 1104 in theretractor 1000 (see FIG. 3). Bearing member 2200 may be formed of anysuitable material, such as high density polyethylene.

Accordingly, bearing member 2200 may be provided so that when the insert2000 is pressed into place within flexible retractor 1000, the outerbody portion 2100 may remain generally stationary with respect to theretractor 1000, while the instrument channel member 2500 is rotatablewithin the retractor. Rotation of the member 2500 permits rotationalpositioning of the instrument openings 2014 and passageways 2550 toprovide desired positioning of one or more instruments extending throughinsert 2000.

The instrument channel member 2500 is shown comprising a plurality ofinstrument channels 2540, each instrument channel comprising aninstrument passageway 2550. The instrument channel member 2500 may beadvantageously formed as a one piece, unitary structure formed from adeformable, resilient material such as polyisoprene, Kraton, orSanoprene, on that each instrument channel 2540 is independentlydeformable with respect to the housing 2700 and to the other instrumentchannels. Accordingly, instruments inserted into the instrumentpassageways 2550 may be angled and/or pivoted with respect to eachother, allowing for increased freedom of motion of each instrumentrelative to the others. If desired, a seal member 2544 or otherconstriction may be provided at the distal end of each instrumentchannel 2540 for providing sealing about an instrument positioned withinthe instrument channel 2540.

In the figures, the instrument channels 2540 are shown to be generallycylindrical in shape, and extending distally from a proximal base 2510.Openings 2514 in the base 2510 correspond to and are generally alignedwith the instrument openings 2014 by recesses 2520 formed in the uppersurface of the base 2510. The recesses 2520 may be positioned to matewith features on the underside (distal side) of the inner housing 2700.

The protrusions 2114 formed in the inner surface of outer body portion2100 may operatively engage a feature, such as a circumferentiallyextending groove 2714 formed in an outer cylindrical surface 2710 of theinner housing 2700. The protrusions 2114 engage groove 2714 to restrainthe inner housing 2700 axially (i.e. in the proximal and distaldirections) with respect to the outer body portion 2100, whilepermitting rotation of the inner body portion 2700 with respect to theouter body portion 2100. Alternatively, the body portion 2100 couldinclude a groove, and the inner housing 2700 could include a protrusionfor engaging such a groove.

Inversion constraint member 2300 may be provided to prevent instrumentchannels 2540 from becoming “inverted” (e.g. in the manner of a shirtsleeve being pulled inside out) when an instrument is withdrawn from thechannel 2540. The member 2300 is shown having a generally disc shapedbody 2320 having apertures 2340 extending therethrough. Each aperture2340 can be sized to fit over the distal end of a correspondinginstrument channel 2540. The member 2300 may be formed of any suitablematerial, including for instance polyisoprene, Sanoprene, or Kraton. Theflexibility of the member 2300 may be tailored with respect to theflexibility of more proximal portions of the insert 2000. For instance,if member 2300 is made relatively more flexible than a proximal portionof the insert 2000 (such as the instance the top surface of the housing2700), then instruments inserted in the instrument channels will tend topivot about a fulcrum associated with the more proximal portion of theinsert. Alternatively, if the member 2300 is made relatively more rigidwith respect to the more proximal portions of the insert 2000, then theinstruments will tend to pivot about a fulcrum associated with themember 2300. As shown in FIG. 3, the member 2300 may be positionedaxially between bearing member 2200 and spacer 2400, and the member 2300may be positioned radially inward of the distal portion of the innerhousing 2700.

FIGS. 5 and 6 and illustrate an alternative embodiment of an accessdevice according to the present invention. The access device showncomprises an assembly of a flexible tissue retractor 1000, an insert2000, and a sleeve 3000. The flexible tissue retractor 1000 and theinsert 2000 can be of any suitable form, including as described abovewith respect to FIG. 1-4.

Sleeve 3000 may be provided to assist in preventing the insert 2000 frombeing pressed through the retractor 1000 and into a body cavity, and toassist in removing the insert 2000 from the retractor 1000. Forinstance, during a surgical procedure it may be desirable to interchangeone or more inserts in a tissue retractor 1000 without removing thetissue retractor 1000 from the incision. Sleeve 3000 may also beprovided to protect the retractor 1000 from being torn or otherwisedamaged by instruments inserted through insert 2000. In one embodiment,multiple inserts 2000 may be provided for a specific procedure, eachinsert having a different shape, a different size, a different number ofinstrument openings, and/or different instrument opening sizes. Or, itmay be desirable to remove an insert 2000 from the retractor positionedin the incision, such as to withdraw an instrument, apparatus, tissue,or body organ through the passageway of the tissue retractor 1000.

Referring to FIGS. 5 and 6, the sleeve 3000 may comprise a generallyannular portion 3100 and a generally cylindrical portion 3200. Thegenerally annular portion 3100 is shown having a generally flat proximal(upper) surface 3110, and an opposite, generally flat distal (downward)surface 3120. Sleeve distal surface 3120 may abut or otherwise contactor face the proximal portion of flexible tissue retractor 1000 when thesleeve 3000 is fully positioned with respect to retractor 3000 andinsert 1000.

The generally cylindrical portion 3200 is shown extending distally from,and at substantially a right angle to, the annular portion 3100. Thegenerally cylindrical portion 3200 is shown including a radiallyoutwardly facing surface 3210 and an inwardly facing surface 3220. Theinwardly facing surface 3220 provides a passageway 3104. The generallycylindrical portion 3200 extends at least partially through the flexibletissue retractor 1000, and in FIGS. 5 and 6 the generally cylindricalportion 3200 extends through the retractor 1000 to extend distallybeyond the distal end of the retractor 1000.

In FIGS. 5 and 6, the insert 2000 is shown diposed within the passageway3104 provided by generally cylindrical portion 3200 of sleeve 3000.Sleeve portion 3200 is, in turn, shown disposed within the flexibletissue retractor 1000. The insert 2000, sleeve 3000, and flexible tissueretractor may be assembled in any desired order, either before or afterthe tissue retractor is positioned in an incision. For instance, insert2000 may be pressed into sleeve 3000, and the sleeve/insert subassemblymay then be pressed into retractor 1000 either before or after theretractor is positioned in the incision. Alternatively, the sleeve 3000may be pressed or otherwise inserted into the retractor either before orafter the retractor is positioned in the incision, and the insert maythen be pressed into the sleeve.

Generally, the tissue retractor 1000 will first be inserted into anincision, such as by deforming one or both rings 1200/1400 to insert theretractor in the incision, or by using an insertion tool to insert theretractor in the incision. The sleeve 3000 may then be inserted into theretractor 1000, such as by pressing the sleeve into the retractor. Theinsert 2000 may then be inserted into the sleeve 3000.

The sleeve 3000 is shown having a member such as a retention feature forpreventing the insert from being pressed completely through thesleeve/retractor into the body cavity, and to assist in removing theinsert 2000 from the retractor. Referring to FIG. 6, a retention featurein the form of a generally circumferentially extending ledge or lip 3300is shown extending generally radially inwardly at a distal end of thegenerally cylindrical portion 3200 of sleeve 3000. The lip 3300 may becircumferentially continuous, and may be sized and shaped to abuttinglyengage a portion of the insert, such as the distal end of the outer bodyportion 2100.

In the embodiment shown in FIGS. 5 and 6, when the insert 2000 and thesleeve 3000 are fully inserted within retractor 1000, the seals 2544 arepositioned below the distal end of the retractor 1000. Such anarrangement can provide an instrument pivot point below the retractor,and within the body cavity.

If desired, the insert 2000 and/or sleeve 3000 may be partiallywithdrawn from the fully inserted configuration shown in FIGS. 5 and 6,in a proximal direction to reposition the distal end of the insert 2000with respect to the retractor 1000. Accordingly, the positions where thesurgical instruments exit the insert 2000 can be varied in a generallycontinuous manner along the axis 70, and the point where instrumentsexit the insert 2000 can be located at a plurality of positions withinthe passageway provided by the retractor, or distally below the distalend of the retractor.

If desired, a kit may be provided with different inserts 2000, differenttissue retractors 1000, and/or different sleeves 3000. For instance, thekit may include a plurality of tissue retractors 1000, each sized and/orshaped for a different incision size. The kit may include a plurality ofinserts 2000 having different instrument openings sizes and/orconfigurations. The kit may include sleeves with generally cylindricalportions having different lengths and/or diameters.

In order to withdraw the insert 2000 from the retractor 1000 andincision, a portion of the sleeve 3000, such as the annular portion3100, may be gripped with one or both hands (such as at opposite sidesof the annular portion 3100), and the sleeve may be pulled proximally(upward in FIGS. 5 and 6) to withdrawn the sleeve 3000 and insert 2000from the tissue retractor 1000.

The sleeve 3000 may be formed of a non-metallic plastic or elastomericmaterial. The sleeve 3000 may have a thickness of between about 0.004inch and 0.025 inch, and may be formed of a relatively low friction,high puncture resistant material having a relatively high elongationbefore tearing, and be relatively resistant to silicone or otherlubricants without breaking down or degrading. One suitable sleeve 3000can be formed of sheet or film having a thickness of about 0.005 inch toabout 0.007 inch. Sleeve 3000 may be formed to have a coefficient offriction less than that of the retractor 1000, and the coefficient offriction of the sleeve 3000 can be less than about 0.25, moreparticularly, less than about 0.20, and still more particularly, lessthan about 0.15.

In one embodiment, sleeve 3000 may be formed of a relatively stiff,non-metallic plastic or elastomeric material having a hardness greaterthan the hardness of the tissue retractor, and a flexibility less thanthat of the tissue retractor. In another embodiment, the sleeve may beformed of a material that is relatively soft and flexible. One suitablematerial from which sleeve 3000 may be formed is a thermoplasticpolyurethane elastomer such as a Pellethane brand polyurethane availablefrom Dow Chemical.

Multiple inserts 2000 may be provided, such as two, three, or moreinserts may be provided in a kit form for use in a single surgicalprocedures. For example, a first insert may be provided having two ormore instrument openings, and a second insert may also be providedhaving multiple instrument openings. The first and second inserts mayhave the same number of instrument openings, or a different number ofinstrument openings.

FIG. 7 is an schematic exploded view of an insert 2000 similar to thatshown in FIG. 4, but having three instrument openings 2600, versus fourinstrument openings as shown in FIG. 1. In FIG. 7, the three instrumentopenings include one relatively larger instrument opening (such as toreceive a laparascope or other relatively larger diameter device), andtwo relatively smaller instrument openings (such as to receiverelatively smaller devices, such as 5 mm graspers, clip appliers, or thelike). As shown in FIG. 7, the instrument channel member 2500 has threeinstrument channels corresponding to the three instrument openings, withone of the instrument channels shown being relatively larger in diameterthan the other two instrument channels. The insert 2000 of FIG. 7 canhave generally the same shape and diameter as that of FIG. 1.Alternatively, if desired, the insert could have a different diameterand/or a different shape.

FIG. 8 is a schematic depiction of how the insert of FIG. 7 can beinserted into a sleeve 3000 (shown in half section), and the insert 2000and sleeve 3000 can, in turn, be inserted into a flexible tissueretractor 1000 (also shown in half section). As described above, thesleeve 3000 can include a retention feature in the form of a generallycircumferentially extending ledge or lip 3300 is shown extendinggenerally radially inwardly at a distal end of the generally cylindricalportion 3200 of sleeve 3000. The lip 3300 may be circumferentiallycontinuous, and may be sized and shaped to abuttingly engage a portionof the insert, such as the distal end of the outer body portion 2100 ofthe insert. If desired, the sleeve 3000 can be formed of a relativelyresilient material, and the inner diameter of the portion 3200 of thesleeve 3000 can be sized to engage the outer surface of the insert (suchas by having a slightly smaller diameter than the insert 2000) so thatthe insert can be releasably positioned at multiple insertion depthswithin the portion 3200. In this way the insert 2000 can be positionedat multiple insertion depths with respect to the flexible tissueretractor, with feature 3300 being operable to prevent the insert frombeing inadvertently pushed into the body cavity.

FIG. 9 illustrates a tissue retractor 1000 disposed in an incision intissue 60, with insert 2000 releasably supported in the sleeve 3000, andsleeve 3000 in turn releasably supported within the tissue retractor1000. The insert 2000 is shown disposed at the distal end of sleeve3000, with the distal end of the insert abutting againstmember/retention lip 3300 of the sleeve.

FIG. 9 also illustrates the sleeve 3000 can have an axial length longerthan the axial length of the retractor 1000. If desired, the sleeve canbe positioned at various depths within the retractor, so that the distalend of the sleeve (e.g. the distal end of the cylindrical portion 3200)can be positioned proximal or distal of the distal end of the retractor.In FIG. 9, the distal end of the sleeve is shown disposed distally(below) the distal end of the tissue retractor 1000, an that theinstrument exits 2016 of the insert 2000 are positioned below theabdominal wall. The retention feature (e.g. lip member 3300) preventsthe insert from being unintentionally pushed into the abdominal cavity60A. The feature 3300 also facilitates removal of the insert 2000 withthe sleeve 3000 when the sleeve is withdrawn proximally from theflexible retractor 1000. Accordingly, the retractor can be left in theincision after removal of the sleeve 3000 carrying the insert.

FIG. 10 is a perspective view illustrating how the sleeve 3000 andinsert 2000 can be removed by fingers of a single hand grasping theedges of the portion 3100 of sleeve 3000 and lifting the sleeveproximally (upward in FIG. 10), with the insert carried and retained bythe sleeve 3000. The insert is shown being removed along with the sleevewhen the sleeve is withdrawn from the retractor 1000, and with theretractor left in place in the incision in tissue 60.

FIG. 11 is a perspective view showing how, once the sleeve 3000 andinsert 2000 have been removed from the passageway provided by flexibleretractor 1000, a specimen and/or specimen bag 5000 can be removedproximally (upward in FIG. 11) from the body cavity (e.g. abdominalcavity 60A) through the passageway of the flexible retractor 1000, suchas with an grasper instrument 6000 inserted through the passageway ofthe retractor.

FIG. 12 shows a cross-sectional schematic illustration of an embodimentwhere an insert 2000 is disposed within a flexible retractor 1000,without the use of a sleeve 3000. The flexible retractor 1000 is shownhaving an internal retention feature in the form of an internal rib orlip 1108 for retaining the insert 2000 at a desired depth within theretractor. In FIG. 12, the lip 1108 is shown positioned about midwayalong the length of the passageway provided by retractor 1000, so thatthe distal end of the insert 2000 is disposed about midway along thelength of the passageway of the retractor.

FIG. 12 illustrates how the flexible support of the insert within theflexible retractor 1000 allows an instrument 7000 (e.g. a laparascope orinstrument for manipulating/grasping tissue) extending through aninstrument channel of the insert 2000 can be employed to pivot theinsert 2000 itself, such as to provide an improved range of motion ofthe instrument, as compared to the range of motion provided byinstrument supports and seals mounted above or below a retractor.

FIG. 13 provides a schematic cross-sectional illustration of an assemblycomprising an insert 2000, sleeve 3000, and retractor 1000, where theinsert includes zero closure seals in the form of duckbill seals 2630associated with the proximal end of the instrument access channels (forsealing instrument access channels when no instrument is insertedthrough the channel), and instrument seals in the form of septum seats2640 operatively associated with the distal ends of the instrumentaccess channels for sealing about instruments inserted into theinstrument channels. Alternatively, the seals 2640 could be provided atthe proximal end of the insert, and the seals 2630 could be provided atthe distal end of the insert.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

It is preferred that device is sterilized. This can be done by anynumber of ways known to those skilled in the art including beta or gammaradiation, ethylene oxide, steam, and a liquid bath (e.g., cold soak).

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

1-20. (canceled)
 21. A medical device comprising: a flexible tissue retractor having an outer surface with a tissue engaging portion adapted to engage a body incision and an inner surface defining a passageway; a tubular sleeve member having a portion releasably positionable co-axially within the passageway of the flexible tissue retractor at an axial position coincident with the tissue engaging portion; and an insert comprising at least one instrument opening; wherein the tubular sleeve member is adapted to releasably support the insert with respect to the passageway of the flexible tissue retractor.
 22. The medical device of claim 21 wherein tubular sleeve member and insert are configured to be removed together from the passageway of the flexible tissue retractor.
 23. The medical device of claim 22 wherein the tubular sleeve member and insert are configured to be removed together from the flexible tissue retractor without removing the tissue retractor from a body incision.
 24. The medical device of claim 21 wherein the tubular sleeve member comprises a retention feature for preventing the insert from being pushed through the member and into a body cavity. 